Improving the quality of biomarker discovery research: the right samples and enough of them.

ABSTRACT:

Background

Biomarker discovery research has yielded few biomarkers that validate for clinical use. A contributing factor may be poor study designs.

Methods

The goal in discovery research is to identify a subset of potentially useful markers from a large set of candidates assayed on case and control samples. We recommend the PRoBE design for selecting samples. We propose sample size calculations that require specifying: (i) a definition for biomarker performance; (ii) the proportion of useful markers the study should identify (Discovery Power); and (iii) the tolerable number of useless markers amongst those identified (False Leads Expected, FLE).

Results

We apply the methodology to a study of 9,000 candidate biomarkers for risk of colon cancer recurrence where a useful

SUBMITTER: Pepe MS 

PROVIDER: S-EPMC4452419 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature